gxp Jobs in massachusetts

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Platform Engineer

Takeda pharmaceutical

Boston, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Senior UX Designer

Motion Recruitment Partners, LLC

Boston, Massachusetts, USA

Full-time

About Us We are a leading pharmaceutical research organization advancing breakthrough therapies through cutting-edge science, AI-driven discovery, and global collaboration. Our platforms integrate data, automation, and artificial intelligence to empower scientists working at the forefront of drug development. We're seeking a Senior UX Designer to lead the design of intuitive, intelligent tools used by scientists across the R&D pipeline-from early discovery to translational research. Role Overvi

Staff UX Designer

Motion Recruitment Partners, LLC

Boston, Massachusetts, USA

Full-time

We are a rapidly growing SaaS company serving the life sciences and biotechnology sector, helping research organizations accelerate innovation by transforming raw scientific data into AI-ready assets. Our platform is designed to support complex scientific workflows while meeting the highest standards of data integrity, usability, and compliance. We are seeking an experienced Staff UX Designer to lead the strategic design of user experiences that drive meaningful engagement and scientific impact.

Assoc. Director, PV Systems Reporting & Analytics

Sunrise Systems, Inc.

Remote

Contract

Position Title: Assoc. Director, PV Systems Reporting & Analytics Job ID: 25-09090 Location: Remote Duration: 05 months on W2 Contract Top skills: Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experienceStrong matrix management skills OBJECTIVE: Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) databaseProvide technical and strategic input into the roadmap, planning, and imple

Senior Director, Head of Research Systems Engineering

Johnson & Johnson

Remote or Pennsylvania, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical

Associate Director, Regulatory Data Governance Lead

Takeda pharmaceutical

Boston, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Solution Architect - R&D - In-Silico CMC

Sanofi

Cambridge, Massachusetts, USA

Full-time

Job Title: Solution Architect - RnD Location: Cambridge, MA Morristown, NJ About the Job At Sanofi, we're committed to providing the next-gen healthcare that patients and customers need. It's about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before. At Sanofi Architecture CoE, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build an efficient, reliable and consistent end to end

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

Principal Software Engineer

Amgen Inc

Remote or Thousand Oaks, California, USA

Full-time

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pati

Lab IT Helpdesk | Toronto, Canada | Onsite

Stellent IT LLC

Boston, Massachusetts, USA

Third Party

Title: Lab IT Helpdesk Location: Toronto, Canada | Onsite Duration: 6-12+ Months Must: Helpdesk setting up conferences and meeting rooms - JIRA AWS / AZURE basic cloud technology experience. Local to Toronto from day 3 years helpdesk experience in biotech, 10+ years of general helpdesk experience in general. Most current project needs to be in Biotech. Lab systems experience preferred BENCH LIMS. General LIMS as secondary if no bench LIMS. Description of Position: Reporting into the Director o

CRM Solution Architect, Patient Support Services

Sanofi

Cambridge, Massachusetts, USA

Full-time

Job Title: CRM Solution Architect, Patient Support Services Location: Cambridge, MA Morristown, NJ (Hybrid 3 days a week) About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. We are seeking a skilled, hands-on CRM Solution Architect to join our team. As part of the Patient Services Solution Architecture team,

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Project Manager

Maverick Technology Partners

Andover, Massachusetts, USA

Contract

Project Manager - 5-6 Month Contract - Hybrid North of Boston NO C2C - Must be able to work without sponsorship High Priority project working with multiple internal and external groups within IT and the businessData Integration Project with clients supplied to implement software upgrade. - Need to finish the upgrade and build into their process (which is manual)Knowledge of GXP, Validation, Pharma is a MUSTAgile/Scrum environmentStrong communication skills Nice to Haves: Snowflake is a plus and

Pharmacovigilance Business Analyst

Cygnus Professionals

Remote

Full-time

Position Title: Pharmacovigilance Business AnalystLocation: Remote Duration: 12 plus months contract or Fulltime Requirements: Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.Minimum 10+ years of Business Analyst experience is required.Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.Experience with SQL and

Laboratory Information Management System (LIMS) /ELN Consultant, MN/REMOTE - Direct Client

Javen Technologies, Inc

Remote

Third Party, Contract

Javen Technologies Direct Client is looking for Laboratory Information Management System (LIMS)/Electronic Lab Notebook (ELN) Consultant in Maplewood MN. 100% REMOTE opportunity. If interested, please reach me at / - Gowri. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integra

SAP OTC Solution Architect

NexInfo Solutions, Inc.

Remote

Contract, Third Party

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges

DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLC

Remote or King of Prussia, Pennsylvania, USA

Contract, Third Party

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato